Rigid reinforcing exoskeletal sleeve for delivery of flowable biocompatible materials

Abstract

Exoskeletal devices or sleeves that can be used with the delivery tube of an applicator device to help dispense fluids, typically flowable biocompatible materials such as hemostatic agents, adhesives, or sealants, onto specific sites in the human body for a medical reason are disclosed. The exoskeletal devices or sleeves are rigid, pre-shaped, and snappably or slidably affixed to the delivery tube. The exoskeletal devices or sleeves do not come into contact with the flowable biocompatible fluid being dispensed, and they can be placed at any position along the delivery tube to address different application situations. Once the exoskeletal device or sleeve is in place, it can optionally be locked onto the delivery tube to prevent further sliding under stresses when pushed against tissue. Multiple exoskeletal devices or sleeves can also be used to achieve more complicated shapes for hard-to-reach anatomical sites.

We claim: 
     
         1 . An exoskeletal sleeve for a delivery tube of a medical device for applying an agent to a target anatomical site, wherein said sleeve is rigid, pre-shaped, slidable relative to the delivery tube, and hollow having an internal bore adapted to accept the delivery tube. 
     
     
         2 . The exoskeletal sleeve of  claim 1  wherein the sleeve has a pre-selected angle shape with said angle being more than 0 degrees and less than 180 degrees. 
     
     
         3 . The exoskeletal sleeve of  claim 1  wherein the sleeve has a plurality of pre-selected angles. 
     
     
         4 . The exoskeletal sleeve of  claim 1  wherein the internal bore is circular, elliptical, triangular, square, or polygonal shaped. 
     
     
         5 . The exoskeletal sleeve of  claim 1  wherein the sleeve has an internal diameter from about 0.01 inch to about 0.75 inch. 
     
     
         6 . The exoskeletal sleeve of  claim 1  wherein the sleeve has a length covering from about 2 percent to about 100 percent of the delivery tube. 
     
     
         7 . The exoskeletal sleeve of  claim 1  wherein the sleeve has a length from about 0.5 inch to about 20 inches. 
     
     
         8 . The exoskeletal sleeve of  claim 1  wherein the sleeve has a wall thickness from about 0.004 inch to about 0.2 inch. 
     
     
         9 . The exoskeletal sleeve of  claim 1  wherein the sleeve further comprises a notch for receiving a lock. 
     
     
         10 . The exoskeletal sleeve of  claim 9  wherein the lock is a horse-shoe or U-shaped lock. 
     
     
         11 . The exoskeletal sleeve of  claim 1  wherein said sleeve comprises a tightening nut threaded onto an end of said sleeve, said sleeve having a thread on an external surface at said end, wherein said end has at least one slit. 
     
     
         12 . The exoskeletal sleeve of  claim 1  wherein the sleeve further comprises a bump on an internal wall of said sleeve. 
     
     
         13 . The exoskeletal sleeve of  claim 12 , wherein said bump has a height of from about 0.01 inch to about 0.12 inch. 
     
     
         14 . An exoskeletal sleeve for a delivery tube of a medical device for applying an agent to a target anatomical site, wherein said sleeve comprises an elongated member having an axial channel along an entire length, wherein at least a portion of said channel has a width slightly smaller than an outside diameter of the delivery tube, and wherein said sleeve is rigid, pre-shaped, and snappable onto the delivery tube. 
     
     
         15 . The exoskeletal sleeve of  claim 14 , wherein said sleeve is slidable relative to the delivery tube. 
     
     
         16 . The exoskeletal sleeve of  claim 14  wherein the sleeve has a pre-selected angle shape. 
     
     
         17 . The exoskeletal sleeve of  claim 14  wherein the sleeve has a plurality of pre-selected angles. 
     
     
         18 . The exoskeletal sleeve of  claim 14  wherein the sleeve comprises a circular arc cross section. 
     
     
         19 . The exoskeletal sleeve of  claim 18  wherein the circular arc cross section of the sleeve is an incomplete circle with arc length of less than 2πR. 
     
     
         20 . The exoskeletal sleeve of  claim 18  wherein the circular arc cross section of the sleeve is over ½ of a full circle to about ⅞ of a full circle. 
     
     
         21 . The exoskeletal sleeve of  claim 14  wherein the sleeve has a length covering from about 2 percent to about 100 percent of the delivery tube. 
     
     
         22 . The exoskeletal sleeve of  claim 14  wherein the sleeve has a length from about 0.5 inch to about 20 inches. 
     
     
         23 . The exoskeletal sleeve of  claim 14  wherein the sleeve has a wall thickness from about 0.004 inch to about 0.2 inch. 
     
     
         24 . The exoskeletal sleeve of  claim 14  wherein the sleeve further comprises a notch for receiving a lock. 
     
     
         25 . The exoskeletal sleeve of  claim 24  wherein the lock is a horse-shoe or U-shaped lock. 
     
     
         26 . The exoskeletal sleeve of  claim 14  wherein said sleeve comprises a tightening nut threaded onto an end of said sleeve, said sleeve having a thread on an external surface at said end, wherein said end has at least one slit. 
     
     
         27 . The exoskeletal sleeve of  claim 14  wherein the sleeve further comprises a bump on an internal wall of said sleeve. 
     
     
         28 . The exoskeletal sleeve of  claim 27  wherein said bump has a height of from about 0.01 inch to about 0.12 inch. 
     
     
         29 . A method of delivering an agent to a target anatomical site using a delivery tube, said method comprising the steps of:
 positioning at least one exoskeletal sleeve of  claim 1  on said delivery tube,   maneuvering said delivery tube to said target anatomical site, and   expressing said agent through said delivery tube to said target anatomical site.   
     
     
         30 . The method of  claim 29  further comprising the step of locking said exoskeletal sleeve on said delivery tube before maneuvering said delivery tube to said target anatomical site. 
     
     
         31 . The method of  claim 29 , further comprising the step of positioning a plurality of said exoskeletal sleeves on said delivery tube before maneuvering said delivery tube to said target anatomical site. 
     
     
         32 . The method of  claim 31  further comprising the step of positioning at least one of said exoskeletal sleeves on said delivery tube at a distal end of said delivery tube from which the agent is delivered to a target anatomical site. 
     
     
         33 . The method of  claim 31  further comprising the step of positioning at least one of said exoskeletal sleeves on said delivery tube on a middle section of said delivery tube. 
     
     
         34 . The method of  claim 31  further comprising the step of positioning at least one of said exoskeletal sleeves on a proximate end of said delivery tube from which the agent is delivered to a target anatomical site. 
     
     
         35 . The method of  claim 29  further comprising the step of maneuvering said delivery tube to said target anatomical site through a trocar. 
     
     
         36 . The method of  claim 35  further comprising the step of repositioning the exoskeletal sleeve on said delivery tube during delivery of the agent without removing said delivery tube from said trocar. 
     
     
         37 . A method of delivering an agent to a target anatomical site using an delivery tube, said method comprising the steps of:
 positioning at least one exoskeletal sleeve of  claim 14  on said delivery tube;   maneuvering said delivery tube to said target anatomical site, and   expressing said agent through said delivery tube to said target anatomical site.   
     
     
         38 . The method of  claim 37  further comprising the step of locking said exoskeletal sleeve on said delivery tube before maneuvering said delivery tube to said target anatomical site. 
     
     
         39 . The method of  claim 37 , further comprising the step of positioning a plurality of said exoskeletal sleeves on said delivery tube before maneuvering said delivery tube to said target anatomical site. 
     
     
         40 . The method of  claim 39  further comprising the step of positioning at least one of said exoskeletal sleeves on said delivery tube at a distal end of said delivery tube from which the agent is delivered to a target anatomical site. 
     
     
         41 . The method of  claim 39  further comprising the step of positioning at least one of said exoskeletal sleeves on said delivery tube on a middle section of said delivery tube. 
     
     
         42 . The method of  claim 39  further comprising the step of positioning at least one of said exoskeletal sleeves on a proximate end of said delivery tube from which the agent is delivered to a target anatomical site. 
     
     
         43 . The method of  claim 37  further comprising the step of maneuvering said delivery tube to said target anatomical site through a trocar. 
     
     
         44 . The method of  claim 43  further comprising the step of repositioning the exoskeletal sleeve on said delivery tube during delivery of the agent without removing said delivery tube from said trocar.